Global Head of Regulatory

About Accumulus Technologies

Accumulus Technologies enables life sciences companies and health authorities to exchange information and collaborate through a shared cloud platform. Our focus is on making regulatory collaboration practical: helping customers progress submissions, apply reliance approaches, and coordinate activity across global markets.

The role

We are seeking a senior regulatory leader to provide the expertise, credibility and practical guidance needed to turn regulatory innovation into routine use.

The Global Head of Regulatory reports to the Chief Commercial Officer and will be Accumulus Technologies’ principal regulatory subject matter expert, connecting customer needs, health authority expectations, and platform capabilities. Our current emphasis is on Chemistry, Manufacturing and Controls (CMC), post-approval changes, regulatory reliance and collaborative review, with scope to support initial marketing authorisations and other agreed use cases as we expand.

This is a hands-on leadership role. You will work directly with customers and regulators, help select and shape viable projects, resolve regulatory barriers, and guide colleagues across Commercial, Solution Engineering, Customer Success and Product. Success means more well-qualified sponsor projects progressing into active use, measurable customer value, and repeat adoption.

Key responsibilities

Regulatory strategy and expertise

• Set a focused regulatory strategy aligned with company priorities, customer demand and realistic opportunities for health authority participation.
• Provide authoritative guidance on global CMC lifecycle management, post-approval changes, reliance, work-sharing and collaborative review.
• Assess how differences in dossiers, local requirements, reference approvals and submission timing affect project feasibility.
• Translate regulatory developments into clear recommendations for customers, product priorities and market opportunities.
• Identify where additional specialist or local expertise is needed and coordinate that input.

Customer and commercial support

• Join priority discovery and executive discussions to understand customers’ regulatory objectives, operational constraints and decision criteria.
• Help customers identify suitable products, changes and markets, and define a credible route from initial project to broader adoption.
• Work with Solution Engineering to establish regulatory feasibility, assumptions, dependencies and success measures before commitments are made.
• Help build evidence-based business cases that link regulatory collaboration to operational efficiency, supply continuity, approval timing, and business value.
• Support acquisition, expansion and renewal discussions with regulatory insight, practical examples and credible responses to objections.

Health authority collaboration

• Work with Regulatory Engagement colleagues and regional leads in major markets to secure the right authority participation for priority customer projects.
• Provide the regulatory substance for discussions with authorities, industry groups and collaboration initiatives.
• Help sponsors and authorities agree workable review approaches, information-sharing arrangements and project milestones.
• Convert expressions of interest into defined next steps, with clear owners and dependencies.
• Bring authority feedback into customer planning and platform development.

Customer outcomes and adoption

• Provide senior regulatory guidance during project execution and help resolve issues that could delay or limit customer value.
• Work with Customer Success and Delivery to support the transition from pilots to repeatable operational use.
• Establish an approach to capturing project outcomes, lessons learned and referenceable evidence, with customer permission.
• Develop practical playbooks for project selection, reliance readiness, authority engagement and common regulatory questions.

Product, content and industry leadership

• Translate sponsor and regulator workflows into clear requirements and priorities for Product.
• Review priority demonstrations, proposals, presentations and external materials for regulatory accuracy and relevance.
• Provide regulatory leadership for customer forums with focused agendas and actionable outputs.
• Represent Accumulus Technologies in selected industry and regulatory forums.
• Build internal capability through coaching, training and reusable guidance.

Experience and capabilities

• Substantial senior-level experience in life sciences regulatory affairs, with deep practical expertise in global CMC and lifecycle management.
• A track record of leading complex submissions or post-approval changes across multiple markets and engaging directly with health authorities.
• Practical experience with regulatory reliance, collaborative review or initiatives to modernise regulatory processes.
• Credibility with senior regulatory, quality, manufacturing and supply-chain leaders.
• Experience translating regulatory strategy into operational change, ideally involving digital workflows, regulatory information management or cloud collaboration.
• Commercial judgement: able to assess where a project can create value, where assumptions need testing and where a proposed approach is unlikely to work.
• Clear communication, sound judgement and the ability to influence across functions without relying on hierarchy.
• Willingness to work directly on customer issues in a lean, growing organisation and travel internationally as required.
• A degree in a relevant scientific discipline or equivalent professional experience; an advanced qualification is desirable.

How the role works with the team

The role owns regulatory judgement, strategy and the quality of regulatory guidance. Sales owns account strategy and commercial negotiations; Solution Engineering owns solution scoping; Regulatory Engagement leads authority relationships and regional activation; Customer Success and Delivery own adoption and execution within their respective remits. Product owns the platform roadmap and technical implementation.

The Global Head of Regulatory works across these teams to ensure proposed projects are feasible, commitments are credible and regulatory issues have clear ownership. Sponsors retain responsibility for their submissions and health authorities retain their decision-making authority.

What success looks like

• Priority opportunities have a clear regulatory pathway, appropriate project selection and documented dependencies.
• Regulatory blockers are identified early and promptly resolved or escalated.
• More customers progress from initial projects to repeat use across products and markets.
• Authority engagement results in active participation in relevant projects.
• Customer outcomes provide credible evidence for business cases, expansion and renewal.
• Teams use consistent regulatory guidance and rely less on ad hoc specialist support.